UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028025 |
|---|---|
| Receipt number | R000032090 |
| Scientific Title | Comparison between using PMMA and AN69ST membrane hemofilter in Continuous hemodiafiltration (CPAC study) |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2019/03/28 11:09:32 |
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Basic information
Public title
Comparison between using PMMA and AN69ST membrane hemofilter in Continuous hemodiafiltration (CPAC study)
Acronym
Comparison between using PMMA and AN69ST membrane hemofilter in Continuous hemodiafiltration (CPAC study)
Scientific Title
Comparison between using PMMA and AN69ST membrane hemofilter in Continuous hemodiafiltration (CPAC study)
Scientific Title:Acronym
Comparison between using PMMA and AN69ST membrane hemofilter in Continuous hemodiafiltration (CPAC study)
Region
| Japan |
Condition
Condition
burn, severe acute pancreatitis, sepsis
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the clinical effects of continuous hemodiafiltration between using PMMA and AN69ST membrane hemofilter for the treatment of septic AKI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Changes of scores (SOFA, SAPS2, APACHE2, DIC score, CAI) at 48 and 72 hours after enrollment
Key secondary outcomes
-Duration of mechanical ventilation in 28 days
-Survival rate at 90 days
-ICU stay days
-Hospital stay days
-Changes of plasma lactate and IL-6 level at 72 hours after continuous hemodiafiltration
-Filter lifetime
-Total fluid volume
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Continuous hemodiafiltration using PMMA membrane hemofilter
Interventions/Control_2
Continuous hemodiafiltration using AN69ST membrane hemofilter
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
->=20 years of age
-Able and willing to provide informed consent
-Patients with burn, severe acute pancreatitis or sepsis
-Patients with KDIGO stage 1 screened
-Patients who require continuous hemodiafiltration for more than 24 hours
Key exclusion criteria
-Pregnant women
-Patients with chronic kidney disease or who received RRT before randomization
-Patients with terminal cancer
-Patients with body weight less than 30 kg
-Patients considered ineligible for the study by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Sakurai |
Organization
Faculty of Medicine, Saga University
Division name
Department of Emergency and Critical Care Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga City, Saga
TEL
0952-31-6511
sr0737@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Sakurai |
Organization
Faculty of Medicine, Saga University
Division name
Department of Emergency and Critical Care Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga City, Saga
TEL
0952-31-6511
Homepage URL
sr0737@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
Toray Industries, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical research center, Saga University Hospital
Address
5-1-1 Nabeshima, Saga City, Saga
Tel
0952-34-3400
clinstudycenter@mail.admin.saga-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
佐賀大学医学部附属病院（佐賀県）、唐津赤十字病院（佐賀県）、独立行政法人国立病院機構 嬉野医療センター（佐賀県）、佐賀県医療センター好生館（佐賀県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 30 | Day |
Last modified on
| 2019 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032090
